Section 13.1 has language change to reflect Office of Culture, Ethics, and Compliance's reference
Section 22d.2 removed from smart form as USC IRB no longer provides Spanish translation of consent documents
Section 24.8 now contains a section to document informed consent obtained remotely, similar changes done to Sections 24A and P
(USC only) Ceded Application Changes
Language changes to D1.1, D1.5, D1.5.1-3, D24
For new studies, D1.2 now requires users to categorize the ceded document that was uploaded
Changes for Committee / Staff
BioIRB1 and 2 can now categorize agenda items as "Continuing Review"
"Forward to Expedited-Exempt Reviewer" activity has correct applicable regulation citations
Bug Fixes
Date received no longer changed upon an interim state transition
"Sign Individual Investigator Agreement" activity no longer throws an error upon submission
Page 9 of continuing review for IRB now displays the comprehensive list of study locations, not a subset
Investigators can now select "Military Personnel" and another subject population on Page 22 without receiving an error
Study team members can no longer add division or departments to Section 50c.3 and 50a.3 if a given department/division has no approvers, reviewers, or proxy approvers assigned
Upon copying a study, legacy KC and Cayuse awards/proposal fields no longer propagate from the old study onto the newly cloned study
Can no longer add a user as study team personnel if they are listed as a guest - they must be first removed from guests using the "Edit Guest Access" activity first
Enhancements
Automatic Withdrawal of study applications inactive in study team inbox for 18+ months
Notice to be sent out and auto-withdrawal to be done 30 days after notice is sent
Webservices connection between iStar and diSClose that fires upon submission of research studies and amendments. Entity and study information are sent to discloser's profile (if any) and a research stub is created in disclose for review if there are any possible conflicts
Misc
IACUC
Changes for PI / Study Team
New Species were added: Black smith damself fish, Sardine, Northern anchovy, California halibut, Patrale sole, Pacific Dover Sole, Pacific Sanddab, Olive Rockfish, Blue Rockfish, Kelp Perch, Kelp Bass, Catalina goby, Horn ashark, Dipodomus ordii, Dipodomys agilis, Dopodomys simulans, Dipodomys californicus, Dipodomus herrmanni, and Dipodomys microps
Amendments and Renewals are now automatically withdrawn when Protocols are terminated
Changes for IACUC Committee / Staff
Non Compliance Reports & Monitoring Reports have been updated to reflected the new business of process of the chair no longer needing to confirm minutes.
Multiple Monitoring Reports can now be added to a protocol
Adverse Events for Self Reporting and Anonymous Reporting can now be submitted by the staff
Various miscellaneous bug fixes and enhancements
IBC
Changes for PI / Study Team
Section 1: "Animal Research" is now added to the list of Responsibilities for Personnel
Section 1.4.1: Removed note of "Responses to Apendix M of the NIH guidelines are attached on page 15"
Section 1.15: Replaced SOP link with ABSL-2 webpage + adjusted language to refer to Animal Research Safety Program (USC ONLY)
Section 1.16: Removed 1.16.1 and 1.16.2 and replaced with notice to notify radsafety@usc.edu when 1.16 is answered "Yes" (USC ONLY)
Section 1.17: Removed 1.17.1 and replaced with notice to notify radsafety@usc.edu when 1.17 is answered "Yes" (USC ONLY)
Section 2:
CHLA ONLY
Section 2.4. ECP section Is now required
USC ONLY
Section 2.3 and 2.4 were removed subsequent questions renumbered
Section 2.5 (new 2.3):
Added: "Glass Pasteur pipettes should be substituted with plastic pipettes whenever feasible.
Deleted: "Hand-restrained shall not be used without justification"
Revised wording for safety rotors
Section 2.7 (new 2.5): Combined all checkboxes into one box + Other
Section 2.9 (new 2.7): Changed EHSA to RSS
Section 2.11 (new 2.9): Combined all checkboxes into one box + Other for both inside and outside biosafety cabinet
Section 2.12 (new 2.10): Added point "Incidents should be reported to the Principal Investigator, Supervisor, and Biosafety Office as soon as possible"
Section 2.13 removed
Section 2.14 (new 2.11): Added check box for “Chemical agent and/or Toxin (72 hours)”
Sections 2.15-2.25 removed
Section 12.3: Combined all checkboxes into one box + Other (USC ONLY)
Section 12.2.13: Requirement to upload carcinogen SOP (USC ONLY)
Section 12.7:
Combined all checkboxes into one box + Other (USC ONLY)
Removed point "Lab personnel are aware of the proper way to neutralize chemical in case of spill according to SDS guidelines (Both USC and CHLA)
Added point of "Lab personnel are aware to notify supervisor in case of emergency" (USC ONLY)
Added link to carcinogen SOP page (USC ONLY)
Section 14.5: Split into two questions - 14.5.1 for Laboratory Containment Levels and 14.5.2 for Animal Facility Containment Levels (Only visible when animals are involved)
Submit Changes & Submit Response to Contingencies activities is now only available to PIs and not the entire study team
CVs are now outputted in the Personnel section if the personnel have added a CV to their user profile, eliminating the need to add CVs to the Documents section
"Wilshire" was added to list of buildings for CHLA
Changes for IBC Committee / Staff
Agendas are now specific to each institution, enabling customization specific to the institution
USC Agenda was revamped to show inspection reports, staff summary and project summary
Submit Staff Summary was updated to include fields to update summary and inspection reports
Generate Lab Inspection Printout activity was added to assist with inspections
Reassign Specialist activity was added to easily changed assigned specialists for a BUA
